LAS VEGAS – Be alert for hidden cases of hyperhidrosis in patients, Seemal R. Desai, MD, said during a presentation on this topic at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

During an examination for another condition, he said, patients may be “sweating and dripping.” However, “you look over that diagnosis because that’s not what they’re there for,” said Dr. Desai, a dermatologist at the University of Texas Southwestern Medical Center in Dallas.

He described one of his patients, who only revealed that she suffered from “horrible, devastating” hyperhidrosis after he’d treated her for years for melasma. The sweating especially affected her because it prevented her from wearing the skin-exposing clothing of her Indian culture.

Delays in treatment are common in hyperhidrosis, which is believed to affect 5% of the world’s population. According to Dr. Desai, research suggests that 85% of patients with hyperhidrosis wait more than 3 years to bring it up with doctors, and half wait more than a decade.

There are many treatments for hyperhidrosis. Some are fairly simple: over-the-counter or prescription antiperspirants, said Dr. Desai, who likes the over-the-counter brand Certain Dri), iontophoresis (application of electric current), topical anticholinergics (including glycopyrronium tosylate cloth wipes, recently approved by the FDA for topical treatment of primary axillary hyperhidrosis for ages 9 years and older), and systemic management. Others are minimally invasive: Botox injections and the miraDry medical device (which relies on thermolysis). And surgical strategies may be an option for severe cases.

On its website, the International Hyperhidrosis Society provides a chart of options for hyperhidrosis in various parts of the body. Treatments tend to focus on the underarms, however, and “we’ve got huge unmet needs for patient options,” Dr. Desai said.
 

• During his presentation, he provided the following pearls regarding hyperhidrosis treatments:
• Distinguish between antiperspirants, which block sweating, and deodorants, which cover up body odor. “Sometimes I get caught up in the middle of a busy office visit and use these terms interchangeably. They’re really different, but patients and the public tend to equate those together,” he commented.
• Make sure patients understand how to properly use antiperspirants and explain that antiperspirants must be applied to dry skin. “Antiperspirant is forming a clog in the drain” to prevent the release of sweat, he said. “If you apply it to wet skin, you will block that chemical reaction in the duct.”
• Massage in the antiperspirant, he advises, and don’t occlude the skin. Apply twice daily, including before bedtime. “They can use antiperspirant on the hands and the bottom of the feet,”Dr. Desai said. “You want to ensure that they’re using the spray on the surface and in the web space. They can also use antiperspirants on the face, but avoid contact with the eyes.”
• Be careful if you prescribe glycopyrronium cloths off label. These wipes are helpful and they can be used outside the FDA-approved use in the underarms, said Dr. Desai, who said he has palmar hyperhidrosis and has successfully used them on his palms, but he hasn’t found them to be helpful on the soles of his feet.

Dr. Desai recommends 5-minute applications on the palms because the treatment can irritate the face and eyes.

Linda F. Stein Gold, MD, of Henry Ford Health System in Detroit, told the audience about the case of a teacher who touched his eyes after applying the treatment. He went to school, felt ill, and ended up in an emergency department because he had an enlarged pupil. “You just have to tell people this can happen,” she said.

Dr. Desai reported no relevant disclosures.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Be alert for hidden cases of hyperhidrosis in patients, Seemal R. Desai, MD, said during a presentation on this topic at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

During an examination for another condition, he said, patients may be “sweating and dripping.” However, “you look over that diagnosis because that’s not what they’re there for,” said Dr. Desai, a dermatologist at the University of Texas Southwestern Medical Center in Dallas.

He described one of his patients, who only revealed that she suffered from “horrible, devastating” hyperhidrosis after he’d treated her for years for melasma. The sweating especially affected her because it prevented her from wearing the skin-exposing clothing of her Indian culture.

Delays in treatment are common in hyperhidrosis, which is believed to affect 5% of the world’s population. According to Dr. Desai, research suggests that 85% of patients with hyperhidrosis wait more than 3 years to bring it up with doctors, and half wait more than a decade.

There are many treatments for hyperhidrosis. Some are fairly simple: over-the-counter or prescription antiperspirants, said Dr. Desai, who likes the over-the-counter brand Certain Dri), iontophoresis (application of electric current), topical anticholinergics (including glycopyrronium tosylate cloth wipes, recently approved by the FDA for topical treatment of primary axillary hyperhidrosis for ages 9 years and older), and systemic management. Others are minimally invasive: Botox injections and the miraDry medical device (which relies on thermolysis). And surgical strategies may be an option for severe cases.

On its website, the International Hyperhidrosis Society provides a chart of options for hyperhidrosis in various parts of the body. Treatments tend to focus on the underarms, however, and “we’ve got huge unmet needs for patient options,” Dr. Desai said.
 

• During his presentation, he provided the following pearls regarding hyperhidrosis treatments:
• Distinguish between antiperspirants, which block sweating, and deodorants, which cover up body odor. “Sometimes I get caught up in the middle of a busy office visit and use these terms interchangeably. They’re really different, but patients and the public tend to equate those together,” he commented.
• Make sure patients understand how to properly use antiperspirants and explain that antiperspirants must be applied to dry skin. “Antiperspirant is forming a clog in the drain” to prevent the release of sweat, he said. “If you apply it to wet skin, you will block that chemical reaction in the duct.”
• Massage in the antiperspirant, he advises, and don’t occlude the skin. Apply twice daily, including before bedtime. “They can use antiperspirant on the hands and the bottom of the feet,”Dr. Desai said. “You want to ensure that they’re using the spray on the surface and in the web space. They can also use antiperspirants on the face, but avoid contact with the eyes.”
• Be careful if you prescribe glycopyrronium cloths off label. These wipes are helpful and they can be used outside the FDA-approved use in the underarms, said Dr. Desai, who said he has palmar hyperhidrosis and has successfully used them on his palms, but he hasn’t found them to be helpful on the soles of his feet.

Dr. Desai recommends 5-minute applications on the palms because the treatment can irritate the face and eyes.

Linda F. Stein Gold, MD, of Henry Ford Health System in Detroit, told the audience about the case of a teacher who touched his eyes after applying the treatment. He went to school, felt ill, and ended up in an emergency department because he had an enlarged pupil. “You just have to tell people this can happen,” she said.

Dr. Desai reported no relevant disclosures.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Be alert for hidden cases of hyperhidrosis in patients, Seemal R. Desai, MD, said during a presentation on this topic at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

During an examination for another condition, he said, patients may be “sweating and dripping.” However, “you look over that diagnosis because that’s not what they’re there for,” said Dr. Desai, a dermatologist at the University of Texas Southwestern Medical Center in Dallas.

He described one of his patients, who only revealed that she suffered from “horrible, devastating” hyperhidrosis after he’d treated her for years for melasma. The sweating especially affected her because it prevented her from wearing the skin-exposing clothing of her Indian culture.

Delays in treatment are common in hyperhidrosis, which is believed to affect 5% of the world’s population. According to Dr. Desai, research suggests that 85% of patients with hyperhidrosis wait more than 3 years to bring it up with doctors, and half wait more than a decade.

There are many treatments for hyperhidrosis. Some are fairly simple: over-the-counter or prescription antiperspirants, said Dr. Desai, who likes the over-the-counter brand Certain Dri), iontophoresis (application of electric current), topical anticholinergics (including glycopyrronium tosylate cloth wipes, recently approved by the FDA for topical treatment of primary axillary hyperhidrosis for ages 9 years and older), and systemic management. Others are minimally invasive: Botox injections and the miraDry medical device (which relies on thermolysis). And surgical strategies may be an option for severe cases.

On its website, the International Hyperhidrosis Society provides a chart of options for hyperhidrosis in various parts of the body. Treatments tend to focus on the underarms, however, and “we’ve got huge unmet needs for patient options,” Dr. Desai said.
 

• During his presentation, he provided the following pearls regarding hyperhidrosis treatments:
• Distinguish between antiperspirants, which block sweating, and deodorants, which cover up body odor. “Sometimes I get caught up in the middle of a busy office visit and use these terms interchangeably. They’re really different, but patients and the public tend to equate those together,” he commented.
• Make sure patients understand how to properly use antiperspirants and explain that antiperspirants must be applied to dry skin. “Antiperspirant is forming a clog in the drain” to prevent the release of sweat, he said. “If you apply it to wet skin, you will block that chemical reaction in the duct.”
• Massage in the antiperspirant, he advises, and don’t occlude the skin. Apply twice daily, including before bedtime. “They can use antiperspirant on the hands and the bottom of the feet,”Dr. Desai said. “You want to ensure that they’re using the spray on the surface and in the web space. They can also use antiperspirants on the face, but avoid contact with the eyes.”
• Be careful if you prescribe glycopyrronium cloths off label. These wipes are helpful and they can be used outside the FDA-approved use in the underarms, said Dr. Desai, who said he has palmar hyperhidrosis and has successfully used them on his palms, but he hasn’t found them to be helpful on the soles of his feet.

Dr. Desai recommends 5-minute applications on the palms because the treatment can irritate the face and eyes.

Linda F. Stein Gold, MD, of Henry Ford Health System in Detroit, told the audience about the case of a teacher who touched his eyes after applying the treatment. He went to school, felt ill, and ended up in an emergency department because he had an enlarged pupil. “You just have to tell people this can happen,” she said.

Dr. Desai reported no relevant disclosures.

SDEF and this news organization are owned by the same parent company.

LAS VEGAS – It is important to think outside the box and consider whether secondary causes of hyperhidrosis are at play when a patient complains of sweating too much, a dermatologist told his colleagues.

“Look at where the patient fits into the sweating paradigm,” advised Seemal R. Desai, MD, of University of Texas Southwestern Medical Center in Dallas, and consider factors such as where and how often patients are oversweating.

In cases of secondary hyperhidrosis – those that are caused by another condition – “the key is to really find the underlying cause of the problem and not just try to treat the sweating,” said Dr. Desai, who spoke in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

According to Dr. Desai, the answers to several questions can help pinpoint a diagnosis of primary hyperhidrosis (also known as focal or primary focal hyperhidrosis) or secondary hyperhidrosis:

• Where does the sweating occur?

Sweating occurs over large parts of the body in patients with secondary hyperhidrosis, Dr. Desai said, although it is typically limited to certain areas, such as the armpits, palms, or soles in the primary form.

• When did the sweating begin?

When sweating begins in adulthood, he said, there’s a good chance that it has a secondary cause. Sweating that began in childhood is more likely to be the primary form.

• How does sweating occur at night?

Dr. Desai advised: “Ask about sleep patterns. Do you sweat during your sleep or wake up feeling like you’re sweating?” Sweating throughout a sleep cycle – not “night sweats” that are brief in nature – indicate a probable secondary cause, he said.

According to Dr. Desai, the causes of secondary hyperhidrosis are numerous, including hypoglycemia, neural tumors, and cardiovascular conditions. “Typically, if I’m trying to figure out why a patient is having generalized sweating, the No. 1 cause is medications.”

Dr. Desai reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – It is important to think outside the box and consider whether secondary causes of hyperhidrosis are at play when a patient complains of sweating too much, a dermatologist told his colleagues.

“Look at where the patient fits into the sweating paradigm,” advised Seemal R. Desai, MD, of University of Texas Southwestern Medical Center in Dallas, and consider factors such as where and how often patients are oversweating.

In cases of secondary hyperhidrosis – those that are caused by another condition – “the key is to really find the underlying cause of the problem and not just try to treat the sweating,” said Dr. Desai, who spoke in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

According to Dr. Desai, the answers to several questions can help pinpoint a diagnosis of primary hyperhidrosis (also known as focal or primary focal hyperhidrosis) or secondary hyperhidrosis:

• Where does the sweating occur?

Sweating occurs over large parts of the body in patients with secondary hyperhidrosis, Dr. Desai said, although it is typically limited to certain areas, such as the armpits, palms, or soles in the primary form.

• When did the sweating begin?

When sweating begins in adulthood, he said, there’s a good chance that it has a secondary cause. Sweating that began in childhood is more likely to be the primary form.

• How does sweating occur at night?

Dr. Desai advised: “Ask about sleep patterns. Do you sweat during your sleep or wake up feeling like you’re sweating?” Sweating throughout a sleep cycle – not “night sweats” that are brief in nature – indicate a probable secondary cause, he said.

According to Dr. Desai, the causes of secondary hyperhidrosis are numerous, including hypoglycemia, neural tumors, and cardiovascular conditions. “Typically, if I’m trying to figure out why a patient is having generalized sweating, the No. 1 cause is medications.”

Dr. Desai reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – It is important to think outside the box and consider whether secondary causes of hyperhidrosis are at play when a patient complains of sweating too much, a dermatologist told his colleagues.

“Look at where the patient fits into the sweating paradigm,” advised Seemal R. Desai, MD, of University of Texas Southwestern Medical Center in Dallas, and consider factors such as where and how often patients are oversweating.

In cases of secondary hyperhidrosis – those that are caused by another condition – “the key is to really find the underlying cause of the problem and not just try to treat the sweating,” said Dr. Desai, who spoke in a presentation at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

According to Dr. Desai, the answers to several questions can help pinpoint a diagnosis of primary hyperhidrosis (also known as focal or primary focal hyperhidrosis) or secondary hyperhidrosis:

• Where does the sweating occur?

Sweating occurs over large parts of the body in patients with secondary hyperhidrosis, Dr. Desai said, although it is typically limited to certain areas, such as the armpits, palms, or soles in the primary form.

• When did the sweating begin?

When sweating begins in adulthood, he said, there’s a good chance that it has a secondary cause. Sweating that began in childhood is more likely to be the primary form.

• How does sweating occur at night?

Dr. Desai advised: “Ask about sleep patterns. Do you sweat during your sleep or wake up feeling like you’re sweating?” Sweating throughout a sleep cycle – not “night sweats” that are brief in nature – indicate a probable secondary cause, he said.

According to Dr. Desai, the causes of secondary hyperhidrosis are numerous, including hypoglycemia, neural tumors, and cardiovascular conditions. “Typically, if I’m trying to figure out why a patient is having generalized sweating, the No. 1 cause is medications.”

Dr. Desai reported no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Merkel cell carcinoma, an extremely rare form of skin cancer, is often caused by a subclinical virus that routinely inhabits the skin. Now, a serum test of virus antibody levels is offering insight into the state of the disease, according to one dermatologist.

“If you have these antibodies, you have a better prognosis. You can follow those antibodies to test for recurrence or progression,” Isaac Brownell, MD, PhD, of the Dermatology Branch of the National Institutes of Health said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The cancer appears in the skin’s Merkel cells, which contribute to our sense of touch by helping us to discriminate textures. “When you put your hand in your pocket, and you can tell the difference between the front and back of a quarter,” he said, “you’re using the Merkel cells in your fingertips.”

Only about 2,500 cases of Merkel cell carcinoma appear in the United States each year, Dr. Brownell said. It appears more often in elderly white patients, is more common in men than women, and is more likely among immunosuppressed patients, whose risk is increased 15- to 20-fold. Cases are more common in sunnier regions – at least in men – and lesions frequently appear on the head, face, and neck.

Five-year survival is estimated at 51% if the cancer is localized, according to a 2016 study of 9,387 cases that Dr. Brownell highlighted. But survival declines dramatically if it has spread to lymph nodes or distant sites (Ann Surg Oncol. 2016 Oct;23[11]:3564-71).

In recent years, researchers have linked 80% of Merkel cell carcinoma cases to the Merkel cell polyomavirus, he said. The virus normally inhabits our skin with no ill effects, he said. “We all have this virus on our skin. It’s everywhere, and even children have antibodies,” he said. But mutations can lead to Merkel cell carcinoma.

Does it matter if cases are polyomavirus positive or polyomavirus negative? Not really, Dr. Brownell said, since the presence of the virus doesn’t appear to affect overall prognosis. However, he said, serum antibody testing can be helpful in polyomavirus-positive patients because it offers insight into prognosis and tumor burden. For example, “if the baseline titer falls and then starts to go up, they’re likely to have a recurrence, and you’ll want to look out for that,” he said.

Dr. Brownell offered another bit of advice: Be prepared to respond to patients who worry that they have a contagious virus and could be a danger to others. The proper answer, he said, is this: “You don’t have to worry about infecting people. Your tumor is not making the virus, you’re not infectious, and we have the virus on us already.”

For more information about the antibody test, visit merkelcell.org/sero.

Dr. Brownell reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Merkel cell carcinoma, an extremely rare form of skin cancer, is often caused by a subclinical virus that routinely inhabits the skin. Now, a serum test of virus antibody levels is offering insight into the state of the disease, according to one dermatologist.

“If you have these antibodies, you have a better prognosis. You can follow those antibodies to test for recurrence or progression,” Isaac Brownell, MD, PhD, of the Dermatology Branch of the National Institutes of Health said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The cancer appears in the skin’s Merkel cells, which contribute to our sense of touch by helping us to discriminate textures. “When you put your hand in your pocket, and you can tell the difference between the front and back of a quarter,” he said, “you’re using the Merkel cells in your fingertips.”

Only about 2,500 cases of Merkel cell carcinoma appear in the United States each year, Dr. Brownell said. It appears more often in elderly white patients, is more common in men than women, and is more likely among immunosuppressed patients, whose risk is increased 15- to 20-fold. Cases are more common in sunnier regions – at least in men – and lesions frequently appear on the head, face, and neck.

Five-year survival is estimated at 51% if the cancer is localized, according to a 2016 study of 9,387 cases that Dr. Brownell highlighted. But survival declines dramatically if it has spread to lymph nodes or distant sites (Ann Surg Oncol. 2016 Oct;23[11]:3564-71).

In recent years, researchers have linked 80% of Merkel cell carcinoma cases to the Merkel cell polyomavirus, he said. The virus normally inhabits our skin with no ill effects, he said. “We all have this virus on our skin. It’s everywhere, and even children have antibodies,” he said. But mutations can lead to Merkel cell carcinoma.

Does it matter if cases are polyomavirus positive or polyomavirus negative? Not really, Dr. Brownell said, since the presence of the virus doesn’t appear to affect overall prognosis. However, he said, serum antibody testing can be helpful in polyomavirus-positive patients because it offers insight into prognosis and tumor burden. For example, “if the baseline titer falls and then starts to go up, they’re likely to have a recurrence, and you’ll want to look out for that,” he said.

Dr. Brownell offered another bit of advice: Be prepared to respond to patients who worry that they have a contagious virus and could be a danger to others. The proper answer, he said, is this: “You don’t have to worry about infecting people. Your tumor is not making the virus, you’re not infectious, and we have the virus on us already.”

For more information about the antibody test, visit merkelcell.org/sero.

Dr. Brownell reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

LAS VEGAS – Merkel cell carcinoma, an extremely rare form of skin cancer, is often caused by a subclinical virus that routinely inhabits the skin. Now, a serum test of virus antibody levels is offering insight into the state of the disease, according to one dermatologist.

“If you have these antibodies, you have a better prognosis. You can follow those antibodies to test for recurrence or progression,” Isaac Brownell, MD, PhD, of the Dermatology Branch of the National Institutes of Health said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

The cancer appears in the skin’s Merkel cells, which contribute to our sense of touch by helping us to discriminate textures. “When you put your hand in your pocket, and you can tell the difference between the front and back of a quarter,” he said, “you’re using the Merkel cells in your fingertips.”

Only about 2,500 cases of Merkel cell carcinoma appear in the United States each year, Dr. Brownell said. It appears more often in elderly white patients, is more common in men than women, and is more likely among immunosuppressed patients, whose risk is increased 15- to 20-fold. Cases are more common in sunnier regions – at least in men – and lesions frequently appear on the head, face, and neck.

Five-year survival is estimated at 51% if the cancer is localized, according to a 2016 study of 9,387 cases that Dr. Brownell highlighted. But survival declines dramatically if it has spread to lymph nodes or distant sites (Ann Surg Oncol. 2016 Oct;23[11]:3564-71).

In recent years, researchers have linked 80% of Merkel cell carcinoma cases to the Merkel cell polyomavirus, he said. The virus normally inhabits our skin with no ill effects, he said. “We all have this virus on our skin. It’s everywhere, and even children have antibodies,” he said. But mutations can lead to Merkel cell carcinoma.

Does it matter if cases are polyomavirus positive or polyomavirus negative? Not really, Dr. Brownell said, since the presence of the virus doesn’t appear to affect overall prognosis. However, he said, serum antibody testing can be helpful in polyomavirus-positive patients because it offers insight into prognosis and tumor burden. For example, “if the baseline titer falls and then starts to go up, they’re likely to have a recurrence, and you’ll want to look out for that,” he said.

Dr. Brownell offered another bit of advice: Be prepared to respond to patients who worry that they have a contagious virus and could be a danger to others. The proper answer, he said, is this: “You don’t have to worry about infecting people. Your tumor is not making the virus, you’re not infectious, and we have the virus on us already.”

For more information about the antibody test, visit merkelcell.org/sero.

Dr. Brownell reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

[email protected]

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

[email protected]

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

[email protected]

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

[email protected]

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

[email protected]

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

[email protected]

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

[email protected]

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

[email protected]

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

[email protected]

Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?

Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.

Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.

Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.

The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.

Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.

The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”

Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?

Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.

Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.

Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.

The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.

Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.

The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”

Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?

Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.

Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.

Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.

The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.

Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.

The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”

The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

Olivier Le Moal/Getty Images

The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.

The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.

Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.

The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.

“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.

[email protected]

The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

Olivier Le Moal/Getty Images

The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.

The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.

Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.

The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.

“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.

[email protected]

The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

Olivier Le Moal/Getty Images

The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.

The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.

Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.

The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.

“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.

[email protected]

ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.

Jeff Craven/MDedge News

For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.

“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.

Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.

The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.

At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).

Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).

Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and ­–1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).

Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.

There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.

Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”

When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.

“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.

The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.

SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.

ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.

Jeff Craven/MDedge News

For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.

“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.

Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.

The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.

At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).

Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).

Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and ­–1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).

Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.

There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.

Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”

When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.

“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.

The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.

SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.

ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.

Jeff Craven/MDedge News

For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.

“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.

Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.

The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.

At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).

Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).

Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and ­–1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).

Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.

There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.

Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”

When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.

“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.

The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.

SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.